Takeda Updates On Phase 1/2 Trials Of Novavax And Moderna's COVID-19 Vaccine Candidates In Japan

(RTTNews) - Takeda Pharmaceutical Company Limited (TAK) said Wednesday that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax' COVID-19 vaccine candidate (TAK-019) in Japan.

Earlier this month, Takeda completed enrollment in the company's Phase 1/2 immunogenicity and safety study of Moderna's COVID-19 vaccine candidate (TAK-919) in Japan.

Takeda said it is making two COVID-19 vaccines available in Japan, by manufacturing Novavax' recombinant vaccine candidate and by distributing Moderna's mRNA vaccine candidate.

Takeda noted that the phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination.

Takeda expects results from the TAK-919 study in the first half of 2021 and results from the TAK-019 study in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency.

Takeda plans to start distributing TAK-919 in the first half of 2021 and aims to start distributing TAK-019 in late 2021.

Takeda noted that it will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of over 250 million doses of TAK-019.

The company will also import and distribute 50 million doses of TAK-919 as part of a joint partnership with Moderna and the Government of Japan's Ministry of Health Labour and Welfare (MHLW).